Evidence map›Paper›PMID 34582105›Full record

ArticleClinical and translational science2022

Evaluation of atezolizumab immunogenicity: Efficacy and safety (Part 2).

Solange Peters, Peter R Galle, Coen A Bernaards, Marcus Ballinger, René Bruno, Valerie Quarmby, Jane Ruppel, Alexandr Vilimovskij, Benjamin Wu, Nitzan Sternheim and 1 more

Open access · goldAbstract read
In one paragraph

Article in Clinical and translational science, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 2 pooled it
1.7field-weighted citation impact, top 12% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 2 syntheses or guidelines pooled it, 26 citations in OpenAlex.

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  13. Antibody Drug Clearance: An Underexplored Marker of Outcomes with Checkpoint Inhibitors.Clinical cancer research : an official journal of the American Association for Cancer Research · 2024
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 9 institutions in 6 countries.

Solange PetersOncology Department - CHUV, Lausanne University, Lausanne, Switzerland.
Peter R GalleDepartment of Internal Medicine, University Medical Center of the Johannes Gutenberg-University Mainz, Mainz, Germany.
Coen A BernaardsProduct Development Biometrics, Genentech, Inc, South San Francisco, California, USA.
Marcus BallingerProduct Development Oncology, Genentech, Inc, South San Francisco, California, USA.
René BrunoClinical Pharmacology, Genentech-Roche, Marseille, France.
Valerie QuarmbyBioAnalytical Sciences, Genentech Inc, South San Francisco, California, USA.
Jane RuppelBioAnalytical Sciences, Genentech Inc, South San Francisco, California, USA.
Alexandr VilimovskijProduct Development Safety, F Hoffmann-La Roche Ltd, Basel, Switzerland.
Benjamin WuDepartment of Clinical Pharmacology, Genentech Inc, South San Francisco, California, USA.
Nitzan SternheimProduct Development Regulatory, Genentech Inc, South San Francisco, California, USA.
Martin ReckLung Clinic Grosshansdorf, Airway Research Center North, German Center for Lung Research, Grosshansdorf, Germany.
Bioanalytica (Switzerland) · CHGene Therapy Laboratory · FRLungenClinic Grosshansdorf · DEPlant Gene Expression Center · USRoche (France) · FRRoche (Switzerland) · CHSunesis (United States) · USUniversity Medical Center of the Johannes Gutenberg University Mainz · DEZimmer Biomet (Netherlands) · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Antibody therapeutics can be associated with unwanted immune responses resulting in the development of anti-drug antibodies (ADA). Optimal methods to evaluate the potential effects of ADA on clinical outcomes in oncology are not well established. In this study, we assessed efficacy and safety, based on ADA status, in patients from over 10 clinical trials that evaluated the immune checkpoint inhibitor atezolizumab as a single agent or as combination therapy for several types of advanced cancers. ADA can only be observed post randomization, and imbalances in baseline prognostic factors can confound the interpretation of ADA impact. We applied methodology to account for the confounding effects of baseline clinical characteristics and survivorship bias on efficacy. Adjusted meta-analyses revealed that despite numerical differences in overall survival and progression-free survival between ADA-positive and ADA-negative patients from some studies, ADA-positive patients from studies with an overall treatment effect derived benefit from atezolizumab, compared with their adjusted controls. Based on large, pooled populations from atezolizumab monotherapy or combination studies, unadjusted descriptive analyses did not identify a clear relationship between ADA status and frequency or severity of adverse events. Data also suggested that any ADA impact is not driven by neutralizing activity. Collectively, this exploratory analysis suggests that the potential for ADA development should not impact treatment decisions with atezolizumab.

Indexed as

SafetyTreatment OutcomeAntibodies, Monoclonal, HumanizedAntibodies, NeutralizingClinical Trials as TopicDatabases, FactualHumansImmune Checkpoint InhibitorsNeoplasmsAntibodies, Monoclonal, HumanizedAntibodies, NeutralizingatezolizumabImmune Checkpoint Inhibitors

Identifiers

PMID34582105
PMCPMC8742640
OpenAlexW3203155293

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.